MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2005-07-08 for CONVATEC LOOP OSTOMY ROD 8760 manufactured by Convatec.
[16839882]
The loop was used on the manic pt. After he woke up, he pulled the system (wafer+pouch+loop) out and the loop broke. This case is not an adverse event as there was no untoward effect to the pt. The rod broke and recurrence could be serious.
Patient Sequence No: 1, Text Type: D, B5
[16899785]
Convatec conducted a product investigation and found the complaint "not confirmed". 8 loop rods were examined and all samples were as mfg in sealed packaging. A visual inspection was performed on each of the 8 returned samples. The rods were fully assembled, clean and free of specks and burn marks. There were no indications of stress or other anomalies visible under x10 magnification. There was no visual evidence of specks, burns, cracks, fracutres, gels, voids or excess flashing on the samples. Swivel operation: the swivel on each sample was rotated through 180 degrees ten times, each one operated easily and located positively at 90 degrees intervals. There was no dislocation of the swivels. The swivels were then dislocated (twisted and removed) from the loop rod. There was no permanent deformation or breakage at the end of the rod. Batch record 4a76718 reviewed, no evidence of any nonconformities / anomalies relating to the source of the complaint observed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1049092-2005-00039 |
| MDR Report Key | 736700 |
| Report Source | 05 |
| Date Received | 2005-07-08 |
| Date of Report | 2005-07-08 |
| Date of Event | 2004-12-01 |
| Date Mfgr Received | 2004-12-24 |
| Date Added to Maude | 2006-07-20 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | ADRIENNE MCNALLY |
| Manufacturer Street | 200 HEADQUARTERS PARD DR |
| Manufacturer City | SKILLMAN NJ 08858 |
| Manufacturer Country | US |
| Manufacturer Postal | 08858 |
| Manufacturer Phone | 9089042630 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONVATEC LOOP OSTOMY ROD |
| Generic Name | OSTOMY ROD |
| Product Code | EZP |
| Date Received | 2005-07-08 |
| Model Number | NA |
| Catalog Number | 8760 |
| Lot Number | 4A76718 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 724588 |
| Manufacturer | CONVATEC |
| Manufacturer Address | 200 HEADQUARTERS PARK DRIVE SKILLMAN NJ 08558 US |
| Baseline Brand Name | CONVATEC LOOP OSTOMY ROD |
| Baseline Generic Name | OSTOMY ROD |
| Baseline Model No | NA |
| Baseline Catalog No | 8760 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-07-08 |